Overview

This trial is active, not recruiting.

patients with good quality bone, missing at least one tooth in the upper or lower jaw.

Treatments

nobelspeedy shorty implant, brånemark system mk iii shorty implants

Sponsor

Nobel Biocare

Start date

October 2007

End date

May 2015

Trial size

53 participants

Trial identifier

NCT02180230, T-127

Summary

Surgical and restorative procedures in the posterior region of both the mandible and the
maxilla present a complex task. The posterior regions usually exhibit less favorable bone
quality and less bone volume, while they are exposed to greater loads than anterior regions
of the mouth. Thus short implants (i.e. ≤10 mm) are best to use, which creates a dilemma,
since short implants historically have been associated with higher failure rates than longer
implants. However, no direct correlation between implant length and stability, anchorage or
bone stress, have been demonstrated. Instead poor bone quality is likely the most
significant factor associated with short implant failure.

Development of implant design, surface structure and improved surgical technique have proven
short implants to be a viable concept with survival rates comparable to longer implants.

The aim of the study is to evaluate marginal bone level and soft tissue response over time,
around immediately loaded NobelSpeedyTM Shorty and Brånemark System® Mk III Shorty implants
in daily use.

Primary Outcomes

Secondary Outcomes

Measure

Soft tissue Health including papilla index and periimplant mucosa

time frame:
yearly from baseline up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria:
- The subjects should have an osseous architecture enough to receive an implant with a
diameter of at least 3.75 mm for Brånemark System Mk III Shorty or 4 mm for
NobelSpeedy Shorty and a sufficient amount of bone for placing implants with a length
of 7 mm.
- The final tightening torque at installation should be 35-45 Ncm without further
rotation and should not exceed 45 Ncm.
- The subject as well as the implant site(s) should fulfill criteria for immediate
provizionalization.
- Immediate insertion (e.g. placement of the implant immediately after extraction) will
not constitute an exclusion criterion.
- The implants site(s) should be free from extraction remnants.
- The subject should be healthy and compliant with good oral hygiene.
- The subject should be available for the 5-year term of the investigation.
- Favorable and stable occlusal relationship
Exclusion Criteria:
- Alcohol or drug abuse as noted in patient records or in patient history.
- Health conditions, which do not permit the surgical procedure.
- Reason to believe that the treatment might have a negative effect on the subject's
total situation (psychiatric problems), as noted in patient records or in patient
history.
- The subject is not able to give her/his informed consent to participate.
- Any disorders in the planned implant area such as previous tumors, chronic bone
disease, or previous irradiation.
- Severe bruxism or other destructive habits.